Adverse Effects of ATG/ALG Therapy in Aplastic Anemia

A Study on the Dynamics and Grading Criteria Construction of Adverse Reactions to ATG/ALG Therapy in Aplastic Anemia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07461116

Enrollment

200

Registered

2026-03-10

Start date

2026-02-23

Completion date

2027-12-31

Last updated

2026-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aplastic Anaemia

Keywords

Aplastic Anaemia, ATG/ALG

Brief summary

This prospective, single-center, observational cohort study aims to systematically observe and describe the clinical characteristics of adverse reactions in patients with aplastic anemia undergoing ATG (Anti-Thymocyte Globulin) /ALG (Anti-Lymphocyte Globulin) treatment, providing a data foundation for the development of relevant management strategies. This study plans to enroll 200 aplastic anemia patients undergoing ATG/ALG treatment

Interventions

DRUGATG/ALG

Participants will receive ATG/ALG according to standard dosing protocols as per clinical guidelines. During treatment, we will monitor and document any adverse reactions, including their type, severity, duration, and any necessary interventions or changes in treatment plan.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Meet the diagnostic criteria for aplastic anemia (Camitta criteria); * Receiving ATG/ALG immunosuppressive therapy for the first time;

Exclusion criteria

* Previously received hematopoietic stem cell transplantation; * Aplastic anemia patients receiving ATG/ALG as part of transplant conditioning regimen;

Design outcomes

Primary

Measure	Time frame	Description
Percentage of patients with serum sickness and its severity	Within 4 weeks after ATG/ALG infusion	Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess its severity

Secondary

Measure	Time frame	Description
Percentage of patients with liver and kidney function damage and its severity	During ATG/ALG infusion (typically from d1 to d6) and within 4 weeks after ATG/ALG infusion	Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess its severity
Percentage of patients with infusion reaction and its severity	During ATG/ALG infusion(typically from d1 to d6)	Use Common Terminology Criteria for Adverse Events (CTCAE) Version 5 to assess its severity

Countries

China

Contacts

CONTACTWeiwang Li, PhD

liweiwang@ihcams.ac.cn15332132036

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026